Trial

Phase 1 Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers

Study Director
Rosa M Antonijoan, MD
Start Date
11 / 2020
Trial Phase
Phase I
Trial Status
enrolling
Current Enrollment
Target Enrollment
96 Participants
Overview

This is an exploratory, first-in-human (FIH), single-center, double-blind, randomized, placebo-controlled, single and multiple ascending oral dose study in healthy volunteers.The study will be divided into two parts that will be conducted sequentially. Part A is a SAD study to determine the safety, tolerability and PK of single oral doses of BVL-GSK098 in healthy volunteers. In addition, the last cohort of Part A will investigate the effect of food on the PK of BVL-GSK098. Part B is a MAD study to determine the safety, tolerability and PK of BVL-GSK098 following multiple daily oral doses in healthy volunteers